Search Results for "Ticagrelor India Approval Dcgi Astra"
Original Source: Drug Approvals
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...
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India, in the Asian subcontinent is the world’s fourth largest producer of pharmaceuticals, and is thought as one of the most promising biotech markets in the world. Several important steps...
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Brilinta (TM) - ticagrelor, AstraZeneca's new heart drug
Brilinta - ticagrelor, AstraZeneca's new heart drug is a blood-thinning medicine designed to prevent dangerous blood clots in patients with serious chest pain or previous heart attacks. It re...
On April 28, 2011, the US Food and Drug Administration (FDA) approved Zytiga (abiraterone acetate), for use in combination with prednisone for the second-line treatment of castration-resistant prost...
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India to rescind approved drugs with delayed launches
The Drugs Controller General of India (DCGI) said in a letter to state drug controllers that the Central Drugs Standard Control Organization (CDSCO) will start rescinding approval of drugs that have n...
AstraZeneca's Brilinta rolls out in India
The Indian subsidiary of Anglo-Swedish drug major AstraZeneca (LSE: AZN) yesterday launched its patented antiplatelet drug Brilinta (ticagrelor), used to prevent heart attack, after receiving approval...
ABLE questions Indian approval of Cipla biosimilar
India's Association of Biotechnology Led Enterprises sent a letter to the Drug Controller General of India (DCGI) asking whether the approval of biosimilar Etacept from Cipla Ltd. (Mumbai, India) was...
India CROs Say DCGI Trial-Approval Switch To NDAC Too Costly
India's clinical-research organizations say they are taking a direct hit as a result of the decision by the Drug Controller General of India to cede its authority over clinical trials to the New-Drug...
A New Front: India’s Natco Gets State-level Nod To Sell Copies Of BMS’ Sprycel
Natco has gained approval from a state-level agency rather than India’s DCGI, opening up a new front in the battle between Indian companies and MNCs.
Cadila Healthcare Reported Receiving DCGI Approval For Diabetes Drug
Cadila Healthcare reportedly has received India approval for its diabetes dyslipidemia drug, saroglitizar, named after a word in the language of the Indian state of Gujarat, considered one of the nati...
Anticipating big scope for opportunities for clinical trials in India in the coming years, former Drug Controller General of India (DCGI) Dr Surinder Singh has suggested to the medical community to pu...
India's DCGI Orders Crackdown On Unauthorized Antibiotic Sales
The Drug Controller General of India ordered inspectors to monitor closely all outlets for prescription pharmaceuticals around the country to cut down on misuse of antibiotics and other medicines.
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AIM: This study examined the effects of grapefruit juice on the new P2Y(12) inhibitor ticagrelor, which is a substrate of CYP3A4 and P-glycoprotein. METHODS: In a randomized crossover study, ten healt...
Effect of rifampicin on the pharmacokinetics and pharmacodynamics of ticagrelor in healthy subjects.
PURPOSE: Ticagrelor, a reversibly binding oral P2Y(12) receptor antagonist, is predominantly metabolized by cytochrome P450 3A and both the parent compound and its active metabolite AR-C124910XX are s...
Objectives: To assess the effect of ticagrelor on the pharmacokinetics of tolbutamide (a CYP2C9 substrate), and the effect of tolbutamide on ticagrelor pharmacokinetics. Methods: In this randomized, d...
Clopidogrel is beneficial after ACS. Recent data suggest the superiority of prasugrel or ticagrelor compared with clopidogrel. However, there is no comparison of prasugrel vs. ticagrelor. We performed...
The two newer antiplatelet drugs, prasugrel and ticagrelor have both been incorporated in various national guidelines and are both under consideration for approval or have already been approved by var...
